Cefpodoxime Proxetil

Product NDC
16714-403
11-digit product format
167140403
Labeler code
16714
Product ID
16714-403_3c3d4973-bfda-476f-b094-52ac4648d7f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefpodoxime Proxetil
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA065409
Marketing category
ANDA
Marketing start
2007-06-08
Substance
CEFPODOXIME PROXETIL
Active strength
100 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefpodoxime Proxetil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFPODOXIME PROXETIL100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2TB00A1Z7N
Rxcui309077, 309079

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e28aad34-15f4-8358-f1eb-20900c754318Product name220230125
bd926630-c211-e651-84da-4ef72dbed2c5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-403-01Cefpodoxime Proxetil1 in 1 CARTONGRANULE, FOR SUSPENSION17
16714-403-01Cefpodoxime Proxetil50 mL in 1 BOTTLEGRANULE, FOR SUSPENSION507
16714-403-02Cefpodoxime Proxetil100 mL in 1 BOTTLEGRANULE, FOR SUSPENSION1007
16714-403-02Cefpodoxime Proxetil1 in 1 CARTONGRANULE, FOR SUSPENSION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-403-01ML - Milliliter16714-403854e4a53-eba4-4fa7-93b1-6a969ae4158a12013-03-03
16714-403-02ML - Milliliter16714-40371e5f7f6-49f9-4ee5-8818-577084d6727d12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFPODOXIME PROXETILACTIVE INGREDIENT2TB00A1Z7NCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
CEFPODOXIMEACTIVE MOIETY7R4F94TVGYCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-403CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]7Current NDC, Legacy NDC, 4 package rows20240105_5310de78-22c3-4bee-9956-854e767b6bef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309077cefpodoxime 100 MG in 5 mL Oral SuspensionPSN5310de78-22c3-4bee-9956-854e767b6bef7
309079cefpodoxime 50 MG in 5 mL Oral SuspensionPSN5310de78-22c3-4bee-9956-854e767b6bef7
309079cefpodoxime 10 MG/ML Oral SuspensionSCD5310de78-22c3-4bee-9956-854e767b6bef7
309077cefpodoxime 20 MG/ML Oral SuspensionSCD5310de78-22c3-4bee-9956-854e767b6bef7
309077cefpodoxime (as cefpodoxime proxetil) 100 MG per 5 ML Oral SuspensionSY5310de78-22c3-4bee-9956-854e767b6bef7
309079cefpodoxime (as cefpodoxime proxetil) 50 MG per 5 ML Oral SuspensionSY5310de78-22c3-4bee-9956-854e767b6bef7
309077cefpodoxime 100 MG per 5 ML Oral SuspensionSY5310de78-22c3-4bee-9956-854e767b6bef7
309079cefpodoxime 50 MG per 5 ML Oral SuspensionSY5310de78-22c3-4bee-9956-854e767b6bef7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-403-01167140403011 BOTTLE in 1 CARTON (16714-403-01) / 50 mL in 1 BOTTLE1 bottle2007-06-080000-00-00NoNoCurrent
16714-403-02167140403021 BOTTLE in 1 CARTON (16714-403-02) / 100 mL in 1 BOTTLE1 bottle2007-06-080000-00-00NoNoCurrent